Clinical efficacy and safety: anti-infectives for systemic use

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

Evaluation of medicinal products indicated for treatment of bacterial infections
Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline
Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to address indication-specific clinical data requirements - Scientific guideline
Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis - Scientific guideline
Clinical development of medicinal products for treatment of HIV infection
Clinical evaluation of antifungal agents for the treatment and prophylaxis invasive fungal disease
Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C
Clinical evaluation of medicinal products intended for treatment of hepatitis B
Clinical investigation of medicinal products for the treatment of sepsis
Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)
Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products
Treatment and prophylaxis of respiratory syncytial virus (RSV) disease

Concept papers